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  • Analytical method development and optimization
  • Assay qualification and assay transfer
  • Analysis of samples from process development and process characterization studies to track yield and purity
  • Non-cGMP ICH stability studies for DS (liquid or frozen), in-process, and intermediate material to understand DS and process intermediate material and to establish process hold times
  • Forced degradation studies
  • Elucidation and structure studies
  • Establishment of DS and DP specifications and acceptance criteria
  • IND and BLA writing (3.2.S)
  • Biochemical and biophysical assays
    • Separation techniques for purity: Liquid chromatography (size exclusion, reverse-phase; HPLC, UPLC), CE-SDS and SDS-PAGE
    • Charge variant profiling: CEX-HPLC and iCIEF
    • Particle, sub-visible particle, and size analysis: DLS and MALS
    • Process impurity analysis: ELISA for residual host cell protein and qPCR for residual host cell DNA; endotoxin quantitation by LAL testing
    • Protein content: Spectrophotometric techniques, BCA, and Bradford assays
    • Structural characterization: DSC, Near and Far UV-CD
  • Potency assays
    • ELISA and cell based assays
  • Fine structure characterization
    • Mass spectrometry and LC/MS for identity, glycosylation analysis, chemical and amino acid modifications, and other PTMs
  • Compendial assays from USP or Ph. Eur.
  • BIB can perform QC testing for DS release and formal ICH stability studies to generate data DS expiration.
  • Our AD and QC teams have completed over 63 projects from pre-clinical all the way to commercial stages
    • High quality data that is delivered in a timely fashion
    • Group members are available on a frequent basis to meet with clients
    • Open and transparent data sharing